BPC February 10 update

Immunomedics (IMMU) secures license agreement - shares +22%; Intercept (ICPT) NASH trial changes - shares +5%

Price and Volume Movers

Immunomedics, Inc. (NASDAQ: IMMU) shares surged 22% to $5.23 following its announcement that it has entered into a licensing agreement with Seattle Genetics, Inc. (NASDAQ: SGEN) entitling Seattle with worldwide rights for sacituzumab govitecan (IMMU-132). Seattle will be responsible for initiating the Phase 3 clinical trial of IMMU-132 in patients with metastatic triple-negative breast cancer (TNBC) and submitting the initial Biologics License Application (BLA) to the FDA for accelerated approval. Immunomedics will receive $250m upfront in cash and an additional $50m for rights outside the U.S., Canada and the EU. Up to a further $1.7b is on the table pending certain clinical, development, regulatory and sales milestones. Royalty payments are tiered double-digit royalties based on global net sales. Seattle Genetics will also purchase $15m of common stock, representing a 2.8% percent stake.

Immunomedics also noted today that its key upcoming shareholder meeting has been postponed from February 16, 2017 to March 3, 2017 at 10:00 a.m.

Intercept Pharmaceuticals Inc (NASDAQ:ICPT) shares closed up 5% to $118.51 after trading down over 10% during the pre-market session. The company announced in a conference call that changes have been made to its ongoing Phase 3 REGENERATE trial of Obeticholic acid (OCA) for the treatment of adult nonalcoholic steatohepatitis (NASH) patients. The company noted that the primary endpoint of the trial has changed for interim analysis. The co-primary endpoint has changed from an improvement in liver fibrosis AND NASH resolution to liver fibrosis improvement OR NASH resolution, meaning that the company only has to meet one of the endpoints to succeed. As a result, the number of patients required for analysis will decrease from 1400 to 750, with enrollment to be completed in mid-2017.

Catalyst Biosciences, Inc. (NASDAQ:CBIO) announced a 1:15 reverse stock split to be effective at 5pm today. At the opening of trading on February 13, 2017, Catalyst’s stock outstanding will decrease from approximately 13m to approximately 868,000. Shares closed the session down 6% to $0.515.

BioTime, Inc. (NYSE MKT and TASE: BTX) announced the pricing of its underwritten public offering of 6,481,482 shares at a public offering price of $2.70 per share for gross proceeds of $17.5m. Shares closed down 4% to $2.88.

TRACON Pharmaceuticals Inc (NASDAQ:TCON) shares closed down 14% to $4.15 following its announcement after hours on Thursday that it did not see improvement in progression free survival (PFS) in its Phase 2 trial of TRC105 in recurrent glioblastoma (GBM).

Other major price movers:


Ocular Therapeutix Inc (NASDAQ:OCUL): $8.45; +18%.

Acura Pharmaceuticals, Inc. (NASDAQ:ACUR): $1.14; +16%.

Tetraphase Pharmaceuticals Inc (NASDAQ:TTPH): $5.07; 14%.

Innocoll Holdings (NASDAQ:INNL): $0.66; +13%.

AnaptysBio Inc (NASDAQ:ANAB): $22.52; +12%.



Navidea Biopharmaceuticals Inc (NYSEMKT:NAVB): $0.344; -24%.

Concordia International Corp (NASDAQ:CXRX): $2.45; -14%.

ContraFect Corp (NASDAQ:CFRX): $1.54; -12%.

Galena Biopharma Inc (NASDAQ:GALE): $0.743; -10%.

Cara Therapeutics Inc (NASDAQ:CARA): $14.85; -9%

Pipeline updates (Just AGN today):

Pipeline Database Updates

Drug Stage Catalyst

Cortisol Analog
Dry Eye disease

Phase 3 Phase 3 trial to be initiated 2H 2017.

Brimo DDS
Atrophic Age-related macular degeneration (AMD)

Phase 2 Phase 2 top-line data due 2H 2017.

Crohn's disease

Phase 2b Phase 2b data due 2018.

Androgenic Alopecia

Phase 3 Phase 3 enrollment to be completed 2H 2018.


Phase 2 Phase 2 top-line data released April 5, 2017 - primary endpoint missed. Phase 3 planned.

Major depressive disorder (MDD)

Phase 3 Phase 3 data due 2H 2018.

Maintenance Treatment of Schizophrenia

Approved Approval announced November 13, 2017.

RORγt agonist

Phase 2b Phase 2b trial to be initiated 2H 2017.

Severe acne vulgaris

Phase 3 Phase 3 data released March 27 2017 - primary endpoints met. NDA filing due 2H 2017.

Prophylaxis (migraine)

Phase 2b Phase 2b top-line data due 1H 2018.

Acute (migraine)

Phase 3 Phase 3 initiated July 2016. Data due 1H 2018.

Diabetic macular edema (DME)

Phase 3 Phase 3 trial to be initiated 2H 2017.

Ocaliva (Obeticholic acid (OCA)) - REGENERATE
Adult nonalcoholic steatohepatitis (NASH) patients.

Phase 3 Phase 3 data due 1H 2019.